|
Based on information provided, it cannot be determined that the alleged bleeding event requiring surgical intervention is related to the v.A.C.® granufoam¿ dressing.The patient had an arterial bleed at the wound site prior to v.A.C.® therapy that required cauterization.The v.A.C.® granufoam¿ dressing lot number was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.Device labeling, available in print and online, states: contraindications do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.Warnings bleeding: with or without using v.A.C.® therapy, certain patients are at high risk of bleeding complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal: · patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to: · suturing of the blood vessel (native anastomosis or grafts) / organ · infection · trauma · radiation · patients without adequate wound hemostasis · patients who have been administered anticoagulants or platelet aggregation inhibitors · patients who do not have adequate tissue coverage over vascular structures if v.A.C.® therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.If active bleeding develops suddenly or in large amounts during v.A.C.® therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop v.A.C.® therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.® therapy units and dressings should not be used to prevent, minimize or stop vascular bleeding.· protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Always ensure that v.A.C.® foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.Dressing changes wounds being treated with the v.A.C.® therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48-72 hours, but no less than 3 times a week, with frequency adjusted by the clinician as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48-72 hours; the dressing changing intervals should be based on a continuing evaluation of the wound condition and the patient's clinical presentation, rather than a fixed schedule.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.
|
|
On 26-oct-2023, the following information was reported to kci by the patient's family member: the patient's v.A.C.® granufoam¿ dressing had to be replaced on (b)(6) 2023 due to an "artery bursting".On 07-nov-2023 the following information was provided to kci by the family member: the patient previously experienced an arterial bleed on (b)(6) 2023.The artery was cauterized and the prevena plus¿ therapy unit was placed.When the nurse removed the v.A.C.® granufoam¿ dressing on (b)(6) 2023, the cauterization was allegedly removed with the sponge and the patient's wound began bleeding.Ems was called and the patient was transported to the emergency room for treatment.The physician in the emergency room placed 3 sutures and the bleeding stopped.The dressing was replaced, and the patient was discharged home.On 08-nov-2023, the following information was provided to kci by the nurse: upon removal of the v.A.C.® granufoam¿ dressing, the wound began to bleed.The nurse was unable to get the bleeding to stop so ems was called.In the er the patient received 3 sutures which stopped the bleeding.There is no documentation that the bleeding was a result of a busted artery.V.A.C.® therapy was restarted and the patient was discharged home.The v.A.C.® granufoam¿ dressing lot number was not provided, and the device was not returned; therefore, a device evaluation and device history record review could not be performed.
|
